Metastatic or locally advanced SST2-positive neuroendocrine neoplasms in adults
Conditions
Brief summary
Dose Escalation Phase: Incidence and severity of DLTs., Dose Escalation Phase: Incidence and severity of AEs and SAEs at each dose level., Dose Escalation Phase: Incidence of AEs leading to discontinuation from study drug., Dose Expansion Phase: Nature, incidence, and severity of AEs and SAEs at the Expansion Dose., Dose Expansion Phase: Interruptions at the Expansion Dose.
Detailed description
Dose Escalation Phase: Plasma PK parameters of CRN09682, including Cmax, tmax, AUC0-last, AUC0-inf, and t½., Dose Escalation Phase: Plasma PK parameters of MMAE, including Cmax, tmax, and AUC0-last., Dose Escalation Phase: ORR=PR+CR by RECIST version 1.1 criteria., Dose Escalation Phase: DOR, defined as time from achieving at least a RECIST PR to disease progression., Dose Escalation Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria., Dose Escalation Phase: Safety, tolerability, PK, and response by dose level., Dose Expansion Phase: ORR=PR+CR by RECIST version 1.1 criteria., Dose Expansion Phase: DOR, defined as time from achieving at least a RECIST version 1.1 PR to disease progression., Dose Expansion Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria., Dose Expansion Phase: Radiographic PFS (defined as time from enrollment to disease progression)., Dose Expansion Phase: Changes in somatostatin receptor imaging., Dose Expansion Phase: Plasma concentrations of CRN09682 and MMAE at predose and EOI.
Interventions
None listed
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Escalation Phase: Incidence and severity of DLTs., Dose Escalation Phase: Incidence and severity of AEs and SAEs at each dose level., Dose Escalation Phase: Incidence of AEs leading to discontinuation from study drug., Dose Expansion Phase: Nature, incidence, and severity of AEs and SAEs at the Expansion Dose., Dose Expansion Phase: Interruptions at the Expansion Dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose Escalation Phase: Plasma PK parameters of CRN09682, including Cmax, tmax, AUC0-last, AUC0-inf, and t½., Dose Escalation Phase: Plasma PK parameters of MMAE, including Cmax, tmax, and AUC0-last., Dose Escalation Phase: ORR=PR+CR by RECIST version 1.1 criteria., Dose Escalation Phase: DOR, defined as time from achieving at least a RECIST PR to disease progression., Dose Escalation Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria., Dose Escalation Phase: Safety, tolerability, PK, and response by dose level., Dose Expansion Phase: ORR=PR+CR by RECIST version 1.1 criteria., Dose Expansion Phase: DOR, defined as time from achieving at least a RECIST version 1.1 PR to disease progression., Dose Expansion Phase: DCR=PR+CR+SD by RECIST version 1.1 criteria., Dose Expansion Phase: Radiographic PFS (defined as time from enrollment to disease progression)., Dose Expansion Phase: Changes in somatostatin receptor imaging., Dose Expansion Phase: Plasma concentrations of CRN09682 and MMA | — |
Countries
Spain